Industry News

Mankind Pharma to buy domestic business of Panacea Biotec Pharma. Both companies entered into an agreement to buy the domestic formulations business of Panacea Biotec Pharma, a subsidiary of Sputnik V maker Panacea Biotec for Rs 1,908 crore.

Valneva SE a specialty vaccine company, today announced the initiation of a Phase 3 trial in adolescents for its single-shot chikungunya vaccine candidate, VLA1553.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to extend the approval of Dupixent® (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies.

Sun Pharma Canada Inc Limited announced the launch of CEQUA, a new treatment for Canadians living with dry eye disease. CEQUA (cyclosporine ophthalmic solution 0.09% w/v), a calcineurin inhibitor immunomodulator, is the first dry eye treatment available in Canada that is delivered with nanomicellar (NCELL) technology, which improves the bioavailability and physicochemical stability of cyclosporine to increase ocular tissue penetration.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, the generic version of Ziac®1 Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, of Teva Branded Pharmaceutical Products R&D, Inc.

Idorsia Ltd and Idorsia Pharmaceuticals Japan today announce that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved PIVLAZ™ (clazosentan sodium) 150 mg, a selective endothelin A (ETA) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH). The PMDA approval of PIVLAZ is based on a dedicated Japanese Phase 3 program.

Apprentice.io has raised USD 100 million in Series C funding led by new investor Alkeon Capital Management, with repeat participation from Silverton Partners, Insight Partners, Pacific Western Bank, and new investment by Colorcon Ventures. The company will use the capital to help pharma manufacturers harden their supply chains to keep making patient-critical drugs and adapt vaccines to meet the evolving strains of COVID-19.

Vifor Fresenius Medical Care Renal Pharma announced that the European Commission has approved Tavneos in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis. The approval is consistent with expectations and overall follows the U.S. Food and Drug Administration (FDA) approval of Tavneos in October 2021 for the same indication.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan®1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.

According to IQVIATM sales data for the 12 month period ending November 2021, the Lexiscan® Injection, 0.4 mg/5 mL (0.08 mg/mL) market2 achieved annual sales of approximately $659.9 million*.